A Study of HL40626S Tablets in Healthy Adults

NCT07736586 | Not Yet Recruiting Phase 1

• 1 other identifier: HLD25011-P1-1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-centre, randomized, double-blind, placebo-controlled Phase 1 study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HL40626S tablets following single and multiple ascending oral doses to healthy adult participants aged 18-55 years.

Conditions

Psoriasis (PsO); Skin Disease; Immune System Disease; Skin Diseases, Papulosquamous

Keywords

Phase 1; Healthy Participants; HL40626S; Oral Tablets; IL-23 Receptor Antagonist; Interleukin-23; SAD; MAD; Safety; Pharmacokinetics; Immunogenicity; Pharmacodynamics; IFNγ

Outcome Measures

Primary Outcomes (3)

• Parts 1 (SAD) and 2 (MAD): Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Assess incidence, severity, causality and clinical outcome of treatment-emergent adverse events (TEAEs) graded per CTCAE Version 6.0 to characterize the safety and tolerability of HL40626S in Part 1 (SAD) and Part 2 (MAD).

  From signed informed consent through Day 15 for SAD and Day 29 for MAD.

• Parts 1 (SAD) and 2 (MAD): Incidence of serious adverse events (SAEs) [Safety and Tolerability]

  Assess Incidence, severity, causality, and clinical outcome of serious adverse events (SAEs) graded per CTCAE Version 6.0 to characterize the safety and tolerability of HL40626S in Part 1 (SAD) and Part 2 (MAD).

  From signed informed consent through Day 15 for SAD and Day 29 for MAD.

• Parts 1 (SAD) and 2 (MAD): Proportion of participants with clinically significant abnormal findings in physical examinations, vital signs, clinical laboratory tests, and 12-lead ECG assessments relative to baseline [Safety and Tolerability]

  Abnormal findings from physical examinations, vital sign measurements, laboratory analyses and 12-lead ECG tracings are compared against each participant's baseline values to support the overall safety and tolerability assessment of HL40626S in Part 1 (SAD) and Part 2 (MAD).

  From signed informed consent through Day 15 for SAD and Day 29 for MAD.

Secondary Outcomes (18)

• Part 1 (SAD): Maximum observed plasma concentration (Cmax)

  Predose up to 96 hours (Day 5) post single dose.

• Part 1 (SAD): Time to maximum observed plasma concentration (Tmax)

  Predose up to 96 hours (Day 5) post single dose.

• Part 1 (SAD): Area under the plasma concentration-time curve from time zero to last measurable concentration (AUClast)

  Predose up to 96 hours (Day 5) post single dose.

• Part 1 (SAD): Area under the plasma concentration-time curve extrapolated to infinite time (AUCinf)

  Predose up to 96 hours (Day 5) post single dose.

• Part 1 (SAD): Terminal elimination rate constant (Kel)

  Predose up to 96 hours (Day 5) post single dose.

Study Arms (4)

Part 1(SAD): HL40626S

EXPERIMENTAL

Healthy participants receive single fasting oral HL40626S tablets across sequential dose cohorts (25 mg, 100 mg, 200 mg, 400 mg, 800 mg). Each cohort contains 6 participants. Sentinel dosing applies before full cohort dosing.

Drug: HL40626S tablets

Part 1(SAD): Placebo

PLACEBO COMPARATOR

Healthy participants receive single fasting oral placebo tablets matching HL40626S, one dose per participant. 2 participants per SAD cohort.

Drug: HL40626S placebo

Part 2 (MAD): HL40626S

EXPERIMENTAL

Healthy participants receive once-daily fasting oral HL40626S tablets for 14 consecutive days across sequential cohorts (100 mg, 200 mg, 400 mg). Each cohort contains 6 participants.

Drug: HL40626S tablets

Part 2 (MAD) : Placebo

PLACEBO COMPARATOR

Healthy participants receive once-daily oral matching placebo tablets for 14 days. 2 participants per MAD cohort.

Drug: HL40626S placebo

Interventions

HL40626S tablets DRUG

25 and 100 mg tablets, anticipated dose range to be from 25 to 800 mg.

Part 1(SAD): HL40626S; Part 2 (MAD): HL40626S

HL40626S placebo DRUG

Identical tablets to the drug without the active ingredient.

Part 1(SAD): Placebo; Part 2 (MAD) : Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.
• Between the ages of 18.0 and 55.0 years (inclusive) at the time of Screening.
• BMI between 18.0 and 32.0 kg/m2 (inclusive) at the time of Screening, with a body weight ≥ 50 kg.
• In good general health, as determined by the Investigator.
• Female participants must be non-pregnant and non-lactating.
• Female participants must be of non-childbearing potential, or agree to use dual contraception methods (female participants exclusively in same-sex relationships are exempt from the above contraception requirements), and abstain from ova (egg) donation throughout the entire duration of the study and for at least 90 days after the last dose, and have negative pregnancy test results at Screening (serum) and Day -1 (urine). (Note: As this is a first-in-human \[FIH\] study, the applicable t₁/₂ and corresponding restriction period may be adjusted based on emerging PK data).
• Male participants with female partners of reproductive potential must agree to practice complete abstinence or to use a condom (male participant) plus an additional highly effective method (female partner) of contraception for the duration of the study and for at least 90 days after last dosing (Male participants exclusively in same-sex relationships are exempt from the above contraception requirements); all male participants must also agree to refrain from sperm donation for at least 90 days after the last dose. (Note: As this is a FIH study, the applicable t₁/₂ and corresponding restriction period will be adjusted based on real-time PK data).
• Supine blood pressure (BP) between 90/40 mmHg and 140/90 mmHg at Screening.
• Normal renal function as determined by Investigator following review of clinical laboratory test results, including eGFR ≥ 80 mL/min/1.73 m2, as estimated using the CKD EPI Creatinine Equation (2021).
• Less or equal to 5 cigarettes per week within 6 months prior to Day 1.
• Willing to comply with CRU's COVID 19 policy.

You may not qualify if:

• Clinically significant abnormal medical history, such as gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, drug hypersensitivity, as determined by the Investigator, any abnormal findings on physical examination, VS measurements, ECG or laboratory tests at Screening, Admission or pre dose on Day 1 that, in the opinion of the Investigator, could jeopardize achieving the study objectives and/or compromise the participant's safety.
• Any of the following ECG findings at Screening, Admission and/or pre dose on Day 1:
• Any out-of-range ECG parameter(s) or abnormal finding(s) considered clinically significant by the Investigator.
• Any ECG finding that, in the opinion of the Investigator, may compromise interpretation of ECG for cardiac safety assessments and/or complicate interpretation of events that may occur post dose (e.g., QT not accurately measurable, conduction abnormalities).
• Participants with QTcF \>450 msec (if male) or \>470 msec (if female) will be excluded.
• Resting HR \< 40 bpm or \>100 bpm when vital signs are measured at Screening
• SARS-CoV-2 positive by PCR at Admission regardless of symptoms.
• Unstable cardiovascular disease, including recent (within 6 months of screening) myocardial infarction or cardiac arrhythmia.
• Ongoing liver disease or unexplained liver function test (LFT) elevations, defined as ALT, AST, gamma glutamyltransferase (GGT), alkaline phosphatase (ALP) or total/direct bilirubin \> upper limit of the reference range (ULRR) at Screening or Admission. Participants with confirmed Gilbert's syndrome will not be permitted to enroll in the study.
• Indications of pre-metabolic syndrome and/or systemic inflammation, as suggested by high-sensitivity C-reactive protein (hsCRP) of \> 3 mg/L, elevated erythrocyte sedimentation rate (Male ≥ 15 mm/hr, Female ≥ 20 mm/hr) or Hemoglobin A1c (HbA1c) \>5.3% at Screening.
• History of cancer (malignancy) with the exception of basal or squamous cell carcinoma of the skin.
• Respiratory tract infection (upper and/or lower) treated with antibiotics within 12 weeks of Screening.
• Clinically significant infection or known inflammatory condition or history of clinically significant infection within 28 days prior to study drug administration on Day 1 that, in the opinion of the Investigator, would affect the participant's ability to participate in the trial.
• History of drug or alcohol abuse (as defined by DSM-V) within 12 months prior to Screening.
• Positive test result for alcohol (breath) or drugs of abuse (urine) at Screening or Admission.

Sponsors & Collaborators

• Highslab Therapeutics, Inc.: lead

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, 3004, Australia

Location

MeSH Terms

Conditions

Psoriasis; Skin Diseases; Immune System Diseases; Skin Diseases, Papulosquamous

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Central Study Contacts

Arockiaa P Aarthy Joseph, MBBS

CONTACT

61-459 361 568; a.joseph@nucleusnetwork.com.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be double-blinded. The participants and the clinical personnel involved in the collection, monitoring, revision, or evaluation of AEs, or personnel who could have an impact on the outcome of the study will be blinded with respect to the participant's treatment assignment (HL40626S or placebo).
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential dose-escalation design with separate single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, randomized double-blind placebo control, 3:1 active-to-placebo randomization per cohort.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): August 16, 2026
• Primary Completion (Estimated): February 16, 2027
• Study Completion (Estimated): May 23, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)